Physicochemical and Microbiological Characteristics of Stem Bark Exudate Gum of Cordia millenii Tree in Conventional Release Tablets

The development of a raw material into an acceptable pharmaceutical excipient involves evaluation of the physicochemical and formulation properties of the potential raw material. Results from these evaluations may serve as a guide to subsequent use of the substance. The objective of the study was to evaluate the physicochemical and microbiological properties of the stem bark gum of Cordia millenii tree in conventional release paracetamol tablets. From the physicochemical evaluations, the gum was slightly acidic and soluble in all the aqueous-based solvents, except 0.1 N HCl in which it was sparingly soluble. All the absorptive properties of the gum indicated tablet disintegrating potential for tablet formulation. The total ash of the gum was higher than that of the international standard gum arabic. Micromeritic properties of the gum indicated the need for a flow aid to improve its flowability. There were no harmful microorganisms detected in the gum. Aerobic organisms and moulds and yeast were detected within permissible limits. Tablets formulated using six different concentrations of gum dispersions as a binder were generally soft and failed the USP T80 standard of dissolution, indicating poor binding and drug releasing properties. Quality control properties of three different batches of tablets containing varying concentrations of the dry gum as a disintegrating agent were comparable to tablets containing equal concentrations of corn starch. The in vitro drug releases were similar at all-time points of drug evaluation. The gum can therefore be considered as a good disintegrant in the formulation of conventional release tablets.


Introduction
Exudate gum is one of the two types of plant-based gums obtained from trees and shrubs [1], usually by breakdown of cell walls of certain plants, following injury caused by insect borers, human activities (tapping), and diseases and/or under adverse growth conditions such as drought, bushfres, or soil conditions [2][3][4][5][6][7][8]. However, the process of gummosis is suggested as a mode of protective mechanism by sealing of the site of injury against microbial infection and/or excessive loss of water after injury and, therefore, not normal physiological product of metabolism [9][10][11]. Plant gums are hydrosoluble or hydrogel complex nonstarch polysaccharide polymers which are very versatile in application. Most of the functional properties of plant gums depend on the viscosity and swelling properties [6,12]. Gums are ideal excipients of diverse uses in a pharmaceutical formulation of conventional and novel drug delivery systems [7,[13][14][15]. In tablet formulation, gums have been used as binders, solubility enhancers, matrix formers or drug release modifers, flm coating formers, and disintegrants [2,16,17]. Plant-derived polymers comply with many requirements of pharmaceutical excipients. Gums are usually described as being biodegradable and biocompatible with no or low toxicity [7,13,18]. Because gums are natural products, they are obtained from renewable source and extraction and/or purifcation processes pose no risk to the environment. Gums are also characterized by low or no side efects and, therefore, have better patient tolerance and acceptability. Natural gums are easily available worldwide and economical to use, hence contributing to improving the national economy by providing inexpensive formulations to people [17,19,20].
As the use of excipients in drug delivery, especially in the preparation of novel products (modifed drug release dosage forms) increases, the search for suitable and cost-efective and newer natural excipient alternatives becomes necessary [21][22][23][24][25][26][27].
Cordia millenii, commonly called drum tree or African Cordia, from the family Boraginaceae, is a well-distributed tropical African forest tree that can grow up to 20 m, and in some regions (Uganda), it is 40 m high and has a bole diameter of about 1 m or more [28,29]. It is called omo in Yoruba (Nigeria), omah in Benin, because of its use in making talking drums [30,31]. Major uses of Cordia millenii tree are in the area of timber industry and traditional herbal medicine [30,32,33]. In African phytomedicine (where it is an indigenous plant), various parts are used to treat or manage fevers, cough, stomachache, toothache, infammatory-related disorders, HIV, diarrhea, dysentery, ringworm, and worm infestation [30,[33][34][35][36].
Phytochemicals isolated from diferent parts of Cordia millenii plant include glycosides (triterpenoids), resins, lipids, sugars, alkaloids, essential oils, tannins, favonoids (phenolic compounds), steroids, saponins, terpenoid benzoquinones called cordiachromes A-F, and the latest being cordidepsine [29,34,36,37]. When the stem is slashed, viscous liquid oozes out freely after 7-10 days and continues for several weeks. When this viscous liquid is allowed to dry on the tree, it forms a broad mass with fnger-like ribbons.
Te objective of this study is to evaluate the physicochemical and conventional tablet formulation properties of this copious oozing gum from the stem bark of Cordia millenii tree as a binder or disintegrant. Studies carried out on the gum have shown that the gum does not pose any toxicity to humans and is a potential candidate for use as a pharmaceutical excipient in drug formulations [38].
Depending on the ingredients of a solid dosage form such as a tablet, disintegration may proceed to granules and granules deaggregate into primary drug particles. Te process of tablet dissolution can occur from any or all of these at diferent rates. Depending on the efciency of a binding and/or disintegrating agent, dissolution may occur at a slow rate from an intact tablet, at a moderate rate from granules, and/or at a relatively rapid rate from primary drug particles [39]. Terefore, dissolution rate and parameters will be used in this study to evaluate the efciency of the gum as a binder or disintegrant.

Materials.
Te partially dried stem bark gum of Cordia millenii was collected from Miaso Kwahu in the eastern region of Ghana. Leaves and branch parts of this plant were also harvested for identifcation and confrmation at the Department of Herbal Medicine, College of Health Sciences, KNUST, Ghana. Lactose and corn starch were gifts from Aspee Pharmaceuticals (Kumasi, Ghana); polyvinylpyrrolidone (PVP) and magnesium stearate were gifts from Poku Pharmaindustry (Kumasi, Ghana), the model drug; paracetamol (acetaminophen) powder and all the required laboratory grade reagents were obtained from the chemical stores of Departments of Pharmaceutics and Pharmaceutical Chemistry, KNUST, Kumasi. All solutions were prepared with distilled water and were freshly used.

Purifcation of Gum.
Te partially dried gum collected was visually sorted and all nongum materials were removed. Te crude gum was dried in a hot air oven at 50°C till it became sufciently brittle. Te gum was further cleaned by manual scrapping of pieces of bark and other extraneous materials that were not detected before drying. Tis was comminuted through sieve #18 and purifed by the modifed method of Ofori-Kwakye et al. [40].
A weight of 250 g was transferred into 6x its weight (6 × 250 ml) of distilled water for 72 h with occasional stirring for hydration and dissolution. Tis mixture was strained with calico linen, and the fltrate was refltered to ensure that all debris were removed and the volume was adjusted to 1000 ml. Te gum was precipitated with 1.6 volumes of fltrate (1.6 × 1000 ml) of 96% ethanol. Te precipitate was completely dissolved in sufcient (about 300 ml) distilled water, precipitated again with sufcient (375 ml) 96% ethanol, and washed in about 100 ml of diethyl ether and left to stand on the bench for 2 h. It was then dried in a hot air oven at 50°C for 24 h and weighed. Te percent yield was calculated using the following formula: Yield % � weight of purified gum weight of crude gum x 100.
Te gum was powdered using a mortar and pestle and sieved through sieve #80, packed in an airtight container, and labelled as purifed Cordia millenii gum (pCmG).
Tis was confrmed by the ruthenium red test of Choudhary and Pawar [41].

Phytochemical
Screening of pCmG. Te pCmG was screened qualitatively for primary and secondary metabolites.
Other secondary metabolites tested for were tannins by dilute lead acetate and ferric chloride solutions [44,47] and protein and free amino acids using biuret and ninhydrin tests, respectively [44,49]. Flavonoids were tested for by alkaline reagent and ferric chloride solution [44].

Physicochemical Properties of pCmG
(1) Weight Loss on Drying (Moisture Content) and Insoluble Matter Content. Triplicate determinations by BP [50] procedures for acacia gum were used.
(2) Solubility Profle and pH. Tis was evaluated in distilled water, 0.1 N HCl, phosphate bufers of pH 6.8 and 7.4, chloroform, ethanol (96%), and acetone, at room temperature (25°C). Distilled water evaluation was repeated at 80°C. Tree determinations were done for each solvent and expressed in each solvent as the approximate weight (g) of solvent necessary to dissolve 1 g of pCmG at 25°C [50].
Te pH of pCmG was determined using a freshly calibrated Milwaukee 101 pH meter.
(3) Hydration, Swelling, and Water Retention Capacities. Te method adopted by Akpabio et al. [51] was used with some modifcations. Tree 1 g portions of the gum were placed in previously weighed (w 0 ) diferent 15 ml graduated centrifuge tubes, and each was tapped (200 times) till consistent volume (v 1 ) was obtained. Each centrifuge tube containing gum powder was weighed (w 1 ), and 10 ml of distilled water was added into each tube and shaken vigorously for 5 min to obtain uniform dispersion. Te tubes and contents were left for 10 min and centrifuged at 4000 rpm for 10 min. Te supernatant liquid on each sediment was carefully decanted into a 10 ml measuring cylinder and the volume was noted (v f ). Te volume of the sediments was recorded as v 2 , and tubes and content were weighed, w 2.
(4) Moisture Sorption/Desorption Capacity. Te method of Eddy et al. [52] was used with some modifcations. Tree plastic tops were dried at 105°C and cooled in a desiccator, and each was weighed. About 6 g of pCmG powder was also dried at 50°C for 1 h and 1 g was weighed into each plastic top and reweighed. Plastic tops and contents were placed in water in a desiccator and each were weighed daily (24 h) for 7 days (when almost consistent weight was observed). Te tops and contents were transferred into another desiccator containing activated desiccant (dry silica gel) and weighed daily (as above) for 6 days. Te percentage sorption/desorption for each day was obtained as the quotient of mean weight diference per dry gum weight multiplied by 100. Tis was plotted against the number of days.
(5) Inorganic Content of pCmG Powder. Tis was evaluated by determining the total ash, water-insoluble ash, and acidinsoluble ash of the pCmg powder sample.
Total ash value: Triplicate determinations of total ash value were done using the BP [50] method for determining sulfated ash with some modifcation. Tree ash crucibles were heated to redness in a hot air oven for 30 min and allowed to cool in a desiccator. Te crucibles were quickly weighed (A) and three portions of 2 g of gum were placed in each crucible and spread evenly. Each crucible and content were dried at 105°C for 1 h and transferred into a furnace for 4 h at 550°C. Te furnace was allowed to cool to about 180°C and maintained for 20 min. Te crucibles and content were carefully transferred into a desiccator, cooled, and reweighed (C). Te % total ash value of the gum sample in each crucible was calculated as [(C − A)/2 g (weight of gum)] × 100, and the mean was determined. Water-insoluble ash: Te total ash in each was carefully washed with 25 ml of hot distilled water into, respectively, labelled beakers and each was boiled gently for 5 min. Te mixtures were each fltered through an ashless flter paper, and each beaker was washed thoroughly with hot distilled water on their respective ashless flter papers. Each ashless flter paper was allowed to drain completely and carefully transferred to respective crucibles, dried at 105°C, and ignited at 550°C in the furnace for 4 h. Te furnace was allowed to cool to about 180°C and maintained for 20 min. Te crucibles and contents were carefully transferred into a desiccator, cooled, and reweighed (D).
Te % water-insoluble ash of the gum sample in each crucible was calculated as [(D − A)/2 g (weight of gum)] × 100, and the mean of the three crucibles was calculated as water-insoluble ash of the gum [53,54].
Acid-insoluble ash: For the acid-insoluble ash, the BP [50] method was used with some modifcations from other researchers [53,55]. Procedure for determining total ash was repeated and proceeded by carefully washing the ash in each crucible with a mixture of 15 ml distilled water and 10 ml HCl (3 : 2) into labelled beakers. Each beaker was covered with watch glass and boiled gently for 10 min and allowed to cool. Te bottom of each watch glass was rinsed with 5 ml hot distilled water into each beaker. Each acid solution was fltered through an ash-less flter paper and the process continued as was done for waterinsoluble ash.
Ethanol-insoluble ash was also determined as done for water-insoluble ash, except that the boiling process of 96% ethanol washings was done using a refux condenser.

Microbial Properties of pCmG.
Microbial viable count analysis using the plate count and agar well difusion methods described by Das et al. [56] was used.

Micromeritic Parameters of pCmG (1) Bulk Densities, Hausner Ratio, and % Compressibility
Measurements. Tirty grams (30 g) of pCmG powder (sieve #80) were carefully transferred into a 100 ml measuring cylinder tilted at about 60°. Te cylinder was straightened and the granules cautiously levelled in the cylinder without disturbing the packing of the entire powder. Te volume of the granules was recorded as the initial volume, V o .
Te initial (fuf or poured) bulk density, D o , was then determined as the ratio of powder mass (M) to the initial volume (V o ).
Tat is, the initial/fuf/poured bulk density, Te cylinder and content were raised through a distance of about 5 cm and allowed to fall on a hard pad (200 times) until constant volume V f was obtained.
Te fnal (equilibrium/tapped/consolidated) density, D f , was determined as M/V f .
Hausner ratio was evaluated as the quotient of tapped density, D f , and initial bulk density, D o (D f /D o ), and % compressibility (Carr's index) was also calculated as (2) Angle of Repose. Te fxed height cone method was employed. A funnel with the stem cut fat was clamped about 10 cm above a graph paper spread on a fat surface. Fifty grams (50 g) of the gum powder were poured through the funnel to form a cone on the graph paper. Te funnel was carefully adjusted for the tip of the stem to touch the apex of the cone. Te funnel was frmly clamped and the gum powder was collected. Te procedure was repeated such that the apex of the cone just touched the tip of the stem of the funnel. Te base of the cone on the graph paper was marked severally and the diameter, d, measured after the powder was collected. Te height, h, of the cone was measured as the tip of the stem of the funnel to the graph paper. Te angle of repose was calculated as the tangent of the angle ө � 2 h/d. Te entire procedure was repeated three times for each gum.

Binding and Disintegrating Potentials of pCmG in Conventional Release Tablets
(1) Gum-Drug (Paracetamol) Compatibility Testing. Te diamond crystal of the Bruker IR-ATR (infrared attenuated total refectance) spectrophotometer (Model Bruker Alpha Platinum ATR) was cleaned with isopropanol and a background scan was taken. A small quantity of pCmG powder was placed directly on the diamond crystal, and the pressure gauge was applied until maximum contact was obtained. Tis gum sample was scanned through a midwave number of 400-4000 cm −1 . Tis process was repeated for the paracetamol powder alone and the mortar blend of paracetamol-pCmG powder in a ratio of 1 : 1.
Percent quantity of paracetamol in the mixture was determined using the BP [50] procedure of assaying paracetamol tablet. Te rest of the powder mixture was transferred into a sample bottle and stored at 40 ± 2°C and 75% relative humidity in a stability chamber for 30 days [57]. Determination of percent drug content was repeated, and the IR spectrum was generated again. Te spectra were compared for any possible interaction(s) after mixing and/or storage.
(2) Quality assessment of the compressed tablets: Drug content, uniformity of weight, resistance to crushing, and disintegration tests were determined by procedures outlined in BP [50] for compressed tablets. Te dissolution profle was determined using BP [50] and USP 30-NF 25 (2007)  (3) Use of pCmG Powder as Tablet Disintegrant. Table 2 contains master formula of 2 groups of 3 batches of paracetamol tablets. Each group contained 3 batches of pCmG and corn starch (reference) powders as disintegrating agents. Tese batches were labelled as Cm6, Cm8, and Cm10 and ST6, ST8, and ST10, representing pCmG (Cm) and corn starch (ST) groups, respectively. Te numbers 6, 8, and 10 attached to the tablet batches represented the %w/w of pCmG and corn starch per tablet. An appropriate volume of 20% w/v PVP was used as a binder solution to granulate each formulation such that the concentration of PVP was 2.5% w/w per tablet. Te granules were assessed, lubricated with 0.35% w/w of magnesium stearate, and compressed into tablets. Te physical properties and dissolution parameters of the compressed tablets were determined. Te dissolution parameters were compared statistically by the model independent mathematical approach; the ft factors connoted by f1 and f2 represent diference and similarity factors, respectively.
The difference factor computed as f1 � |Rt − Tt| Rt x 100, similarity factor, f2 � 50 log where n � number of sampling time points t, t � 1 to n, R t � cumulative percentage dissolved at time t for the reference, and Tt � cumulative percentage dissolved at time t for the test [59].

Results and Discussion
Te mean percentage yield of pCnG was 38.5%, which was relatively low; however, its pharmaceutical acceptability as an excipient may depend on the physicochemical and formulation characteristics. All the organoleptic properties of the gum were good for use as a pharmaceutical excipient, except the colour which may likely be a slight disadvantage to its use (especially in higher concentrations) in colourless formulations (Table 3). Te positive ruthenium red test confrmed pCmG as a plant gum [60,61]. Apart from the primary metabolites, carbohydrates and reducing sugars, starch and all the secondary metabolites tested for were absent. Tis is a confrmation that gums are not products of metabolism [62] and also attests to the efciency of the purifcation procedure adopted. Te absence of these secondary metabolites in pCmG is an advantage to its use as a pharmaceutical excipient.
Te loss on drying (LOD) and insoluble matter of pCmG were lower than acacia (BP) [50] with values of 10-15 and 0.5%, respectively. Te relatively high insoluble matter value may suggest the presence of high levels of inorganic matter in the gum, and this was confrmed by the total ash value which was higher than that of the international standard gum arabic (2-4% w/w) [63] but lower than that of Khaya senegalensis gum (5.25 ± 0.14%) [64]. Tis high value may not be detrimental to its use as tablet excipient since the acidinsoluble ash which constitutes soil contaminants (silica and silicates) that can cause abrasions on punches and dies of the tablet compressing machine is low.
Moisture content determination for potential pharmaceutical excipient(s) is a useful decisive formulation factor for formulation, storage, and shelf life of pharmaceuticals, especially water-sensitive active pharmaceutical  ingredients (APIs) [51,65]. Furthermore, with knowledge of moisture content, the formulation scientist is able to calculate the exact dry weight of the substance(s) to be used. As shown in Table 3, pCmG may be hygroscopic in nature and may be a good candidate for moisture-sensitive APIs, but when present in high concentration, products may have to be packed in a tight package material.
Te storage of this gum will not depend so much on temperature control [53]. As shown in Table 3, pCmG was soluble in distilled water at room temperature and 80°C and phosphate bufers of pH 7.4 and 6.8, representing pH of the small intestine and colon, respectively, and sparingly soluble in 0.1 N HCl in the stomach. Te solubility of the gum was not afected by temperature. Te lower solubility in 0.1 N HCl may be attributed to the weakly acidic nature of the gum or gum exhibiting pH response characteristics [66], and it is confrmed by the water absorptive parameters of the gum. All the values of absorptive parameters of the gum were lowest in the 0.1 N HCl medium. In the pharmaceutical formulation, the solubility profle of the potential excipient is very necessary as it suggests the type of dosage form appropriate for its use. From the results, appropriate manipulation of the concentration of pCmG can result in tablets that may resist dissolution in the upper GIT [67,68].
Generally, gums exert their optimum functionality when sufciently dissolved or hydrated in water [71]. All the water absorptive parameters (except distilled water) increased with increasing pH of the medium, suggesting disintegration and drug retention functional potentials of this gum when present in a solid dosage formulation. Tis gum will form highly viscous dispersions, and this is a characteristic of linear gums [9]. With all these absorptive properties of high HC, SI, and WRC in pH 7.4 (small intestine) than pH 6.8 (colon), pCmG may be a good drug delivery carrier for colon-targeting preparations and a good tablet disintegrant.
Te infuence of extreme variations of storage conditions such as moisture on the solid-state stability of natural polymer powders was studied on pCmG using a moisture sorption-desorption pattern (Figure 1) [72]. At high humidity (100% RH) environment (room temp. 25°C), pGmG powder steadily adsorbed (sorption) signifcant quantities of moisture to reach the saturation point in 7 days. Even though sorption was rapid, it took 6-7 days to reach hydration equilibrium. Tis conforms to the general observation that hydration equilibrium time increases with %RH [73]. When the same moisture-saturated gum was transferred into an activated silica gel desiccator (extremely low humidity), there was a drastic loss of moisture (desorption). PCmG lost all sorption moisture (desorption) and a small portion of its moisture content within 24 h and continued to lose moisture to hydrous equilibrium on the 7 th day of pCmG in a desiccator containing the dried silica gel. As shown in Figure 1, water loss from pCmG was slow from day 8 to 13. Tis is because the hydrous equilibrium time is longer when water activity in the polymer is high [74]. Since the interaction of pharmaceutical excipients with water can afect some of their physicochemical and mechanical properties, this gum should not be exposed to very low humidity as loss of moisture may lead to excessive dryness that may afect these properties [75]. Te total aerobic viable count or microbial load for pCmG was below BP [50] specifcation. All harmful organisms (Staphylococcus species, Escherichia coli, and Salmonella typhii species) [76] tested for were not detected. Moulds and yeast, usually considered as objectionable organisms, were detected but not in signifcant load as compared to BP [50] standards. On this basis, pCmG can be used as a pharmaceutical excipient in formulation processes and storage of the product, especially liquid dosage products [77].
Using the BP [50] scale of fowability, the angle of repose and Hausner ratio of pCmG powder were good and fair, respectively, with passable percent compressibility index. Tis means that if pCmG is included in tablet formulations, the granules may require glidants to obtain good granule fow during compression. Table 4, the spectrum of freshly blended pCmGparacetamol powders (I) revealed 3 main vibrational peaks of which one is the same as pCmG peak and the other two peaks are within the range of the functional groups in paracetamol. Tere was no indication of the formation of any new functional group, suggesting no chemical reaction and the resulting blend was just a mixture [78]. FTIR PAPs recorded from the spectrum of pCmG-paracetamol blend II, stored for 30 days at 40 ± 2°C at 75% relative humidity, depicted functional groups akin to the fresh blend (Table 4) and the percent concentration of paracetamol being the same. Tese are indications of the stability of the blend and no interaction thereof. Tables 5 and 6 summarize the micrometrics of granules and quality evaluation of compressed tablets of pCmG (Cm) as a binder. Te gum was used in aqueous solutions of diferent concentrations as the granulating agent ( Table 1).

pCmG Used as a Tablet Binder.
As shown in Table 5, the percentage of fne granules was generally high in all the formulations, indicating low tackiness/binding properties of the gum. Tere was no trend as should have been expected.
Generally, the fow properties of granules of all the batches were poor; however, angles of repose were good (Table 5). Tese results agreed well with the fow behaviour of the gum powder; hence, the inclusion of magnesium stearate before compression was necessary.
Formulation batches Cm0.5 and Cm1.0 were too difcult to compress and the resulting tablets were too soft (Table 6) to merit further consideration. As shown in Table 6, only batches Cm2.0 and Cm4.0 with 2 and 4% w/w pCmG, respectively, passed the weight uniformity test. Tis inconsistency in the weight of these batches of tablets may partly be due to the fow properties of the granules. For resistance to crushing (RC) of the compressed tablets, only Cm3.0 and Cm5.0 were considered as passed. Tablets of all batches failed the friability test with high values. Tablets of all the batches passed the DT, even Cm5.0; the batch with the highest concentration (5% w/w) of gum passed the test. None of the batches passed all the quality evaluation tests. Te binding properties of this gum were poor within the concentration range used and may be fully realized if the concentration is increased.

Dissolution Profle of Compressed Tablets.
Generally, there was a good drug (paracetamol) release within the tested period, as shown in Figure 2. All the dissolution curves in Figure 2 were evaluated with USP 30-NF 25 (2007), T 80 standard, and model-independent approach, DE%, to obtain Table 7.
DE% values enable the efective distinction of drug release of the various batches [59,79]. From DE%, drug release from the batches was in ascending order of Cm3.0, Cm4.0, Cm5.0, and Cm2.0 ( Table 7). Tablets of batch Cm2.0 with the highest drug release had the fasted DT value of 5.2 min., friability of 15.31%, and RC value of 28.72 N which could not be efectively compared to Cm3.0, Cm4.0, and Cm5.0 which had relatively better hardness qualities (Table 6). Drug release from these 3 batches followed an increasing order of gum concentration, even though DT showed a decreasing order. Cm5.0 with the highest DT (14.37 min) and hardest 42.99 N among the batches of tablets had 98.58% drug release at 60 min dissolution. Tis may suggest pCmG to have some drug-releasing infuence on these tablets, which therefore may be considered to be a potential good tablet binder and disintegrant at higher concentration.  (Table 7). Tis goes to confrm the earlier suggestion of the positive infuence of pCmG on in vitro drug release of tablets. Tables 8 and 9 represent concise descriptions of granules and quality assessments of tablets, respectively, when dry powders of pCmG (Cm) and standard corn starch (ST) were added to the tablet formulations as disintegrants. Te fow characteristics of the granules of all the batches were almost uniform (Table 8). Using the BP [50] scale of fowability, batches with pCmG granules demonstrated fair fow for all parameters and corn starch granules showed varying fow parameters (Table 8).

PCmG as Tablet Disintegrating Agent.
All the batches of tablets containing gum and starch as disintegrants passed the RC and DT tests but failed the friability test. Tablets of all batches, except Cm8 and ST6, failed the uniformity of weight test at the lower limit.
Drug release of ST6 tablets approached 100% and that of Cm6 was closer at the 60 min dissolution. Drug release patterns of ST6 and Cm6 were almost the same (Figure 3(a)). Increasing disintegrants concentration to 8% w/w demonstrated drug release patterns similar to the 6% w/w disintegrant tablets and higher release at each time point (Figure 3(b).
As shown in Figure 3(c), drug release of the 10% w/w disintegrant concentration tablets followed the same pattern as the 6 and 8% concentrations with highest drug release at each time point. Tere was almost 100% drug release for Cm10 and ST10.

Dissolution Profle of Compressed Tablets Containing
Cm and ST as Disintegrants. As shown in Table 10, DE% at 60 min for all the batches of tablets containing the same disintegrant was in the order of Cm6 < Cm8 < Cm10 and ST8 < ST6 < ST10. DE% values revealed the dependency of dissolution on tablet hardness for ST8 tablets. Te dissolution rate of batches containing pCmG as    Figure 3).
Matching the DE values of batches, it was suggested that the disintegration action and drug release profle of tablets of pCmG and corn starch were comparable (Table 10).
T 80 values of tablets of Cm batches decreased with increasing concentration of pCmG, indicating increasing disintegration of tablets into granules and/or deaggregation into primary drug particles for drug dissolution. Time for 80% drug dissolution was lower for the standard corn starch batches and followed a similar pattern as Cm batches (except ST8 batch). Table 11 shows the concise quantifcation of the similarity of the compressed tablets of Cm and ST using the    model independent mathematical diference factor (f 1 ) or similarity factor (f 2 ) [80]. Te maximum f 1 value for all tablets of Cm batches was 9.4%. Tis suggests that the mean maximum difference between drug release from tablets of Cm batches and the mean drug release of tablets of ST was about 9.4 at all the 7 time points of drug-released evaluations for batches Cm6 and ST6. Tis fgure decreased further to 2.98 when the concentration of the disintegrant increased to 10% w/w (Table 11). Tis is an indication that the drug release profle of pCmG as disintegrant was not diferent from that of corn starch, especially at higher concentrations.
Te similarity factor (f 2 ) calculated confrmed drug release rates of Cm and ST to be similar and almost the same at higher concentrations (Table 11)

. Conclusion
All the physicochemical properties concerning the formulation of conventional tablets studied about pCmG revealed good water absorptive parameters, suggesting disintegrating ability. No harmful organisms were detected in the gum, even though total aerobic viable count and objectionable organisms were detected within BP permissible limits, signifying that it can be used as a pharmaceutical excipient in oral formulations and will be generally preferred because of local availability and continuous supply. Te tablet binding property of pCmG was poor but had a good disintegrating ability, similar to standard corn starch.

Data Availability
Te data used to support the fndings of this study are included within the article.

Conflicts of Interest
Te authors declare that they have no conficts of interest.